Ankylosing Spondylitis and Antiphospholipid Antibodies (ASAA)
Primary Purpose
Ankylosing Spondylarthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Ankylosing Spondylarthritis
Eligibility Criteria
Inclusion criteria patients :
- older than 18 years
- with SA according to ASAS criteria
- followed in the Internal Medicine Department of the REIMS University Hospital
- who have given their consent
- affiliated to social security insurance
Exclusion criteria patients :
- minor patients
- patients with autoimmune disease (except the inflammatory bowel disease)
- cancer
- coagulation disorders
- anticoagulant treatment (anticoagulation out for events history thrombus embolism)
- pregnant women
- patients protected by law
Sites / Locations
- Chu ReimsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ankylosing spondylarthritis
Arm Description
Outcomes
Primary Outcome Measures
presence or absence of APLA
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02809300
Brief Title
Ankylosing Spondylitis and Antiphospholipid Antibodies
Acronym
ASAA
Official Title
Prevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief Summary
The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in patients with ankylosing spondylitis (AS).
The secondary objectives are: (1) To determine whether the presence of these antibodies is symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha therapy.
Detailed Description
Methods:
Experimental design: longitudinal study prospective in a single center.
The Ankylosing Spondylitis Assesment Study (ASAS) criteria are: (1) age <45 years, back pain ≥ 3 months, sacroiliitis on imaging and ≥ 1 associated minor criterion, or (2) HLA B27 positive and ≥ 2 minor criteria.
Minor criteria are: inflammatory back pain, arthritis, enthesitis, uveitis, Dactylitis, psoriasis, Crohn's disease, good clinical response to NSAIDs, family history of Human Leukocyte Antigen HLA B27 and inflammatory syndrome.
Plan Investigation:
Patients in the study will be seen first in consultation to gather the necessary information: history taking (including venous and arterial embolic events and obstetric history), the usual treatment, ASAS criteria of therapeutic AS, current and previous, comprehensive physical examination.
APLA will be measured at baseline and at least 3 months if initially positive.
OUTCOME:
The primary endpoint is the presence or absence of APLA: anti-cardiolipin antibodies (CLA) immunoglobulin M (IgM) or immunoglobulin G (IgG), circulating anticoagulant lupus (CCA), anti-beta2 glycoprotéine1 antibodies (β2GP1A) IgM or IgG.
The secondary endpoints are:
The presence of thrombosis (past or present) or obstetrical accident (anterior)
Relationship between the presence of APLA and a particular form of AS (axial or peripheral)
Relationship between the presence of APLA and anti-TNF alpha therapy
Calendar:
The expected study duration is 16 months.
Statistical Analysis Plan A descriptive analysis will be performed. The variables are described by their number and percentage; quantitative variables are described by their mean and standard deviation. A calculation of the prevalence of APLA will be made. Univariate analysis will be performed for the secondary objectives by the Chi 2 test or Fisher exact test according to the application conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylarthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ankylosing spondylarthritis
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood collection
Primary Outcome Measure Information:
Title
presence or absence of APLA
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria patients :
older than 18 years
with SA according to ASAS criteria
followed in the Internal Medicine Department of the REIMS University Hospital
who have given their consent
affiliated to social security insurance
Exclusion criteria patients :
minor patients
patients with autoimmune disease (except the inflammatory bowel disease)
cancer
coagulation disorders
anticoagulant treatment (anticoagulation out for events history thrombus embolism)
pregnant women
patients protected by law
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline ORQUEVAUD
Phone
326832465
Ext
33
Email
porquevaux@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
France
State/Province
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr
12. IPD Sharing Statement
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Ankylosing Spondylitis and Antiphospholipid Antibodies
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